BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE

    MDR report key: 23827170 · Received December 17, 2025

    Report

    Report Number
    2031966-2025-00167
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 26, 2025
    Report Date
    April 2, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517513724
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED A THAT THE TIP OF A RELINE-O FINAL LOCK SCREW DRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, PHOTOGRAPHS OF THE DEVICE PROVIDED BY THE INITIAL REPORTER WERE USED TO CONFIRM THE REPORTED EVENT. A VISUAL EVALUATION OF THE PHOTOGRAPH PROVIDED WAS NOT ABLE TO CLEARLY SHOW THE FRACTURE PATTERN ALTHOUGH THE DISTAL TIP WAS NOTICEABLY FRACTURED OFF AT THE SHANK LEAVING A SUB-FLUSH CRATER AND CONSISTENT WITH OFF ANGLED FORCE AND OR WEAR FATIGUE. NO ASSOCIATED TORQUE HANDLE INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE SURGEON UTILIZED FREE HAND TIGHTENING. MANUFACTURING REVIEW IDENTIFIED LOT NM3960 WAS RELEASED TO THE FIELD ON JUN 01, 2020 AS PART OF FIELD LOANER SETS THAT ARE SUBJECTED TO HANDLING AND REPEATED STERILIZATION CYCLES AFTER DISTRIBUTION INTO THE FIELD. BASED ON THE INFORMATION OBTAINED THE ROOT CAUSE OF THE REPORTED EVENT IS CONSIDERED THE RESULT OF A FATIGUE FAILURE AFTER REPEATED HIGH TORQUE USE OVER TIME. THE FRACTURED TIP, PER SURGEON¿S PREROGATIVE, WAS LEFT IN-SITU AND THE STAINLESS-STEEL MATERIALS THAT WERE UN-RETRIEVED IN THIS EVENT CAN BE CONSIDERED TO EXERT VERY LOW TOXICITY POTENTIAL AND TO POSE NEGLIGIBLE RISK TO THE PATIENT. NO ADDITIONAL INVESTIGATION REQUIRED. MANUFACTURING REVIEW WAS COMPLETED. REVIEW OF THE DEVICE HISTORY RECORD NOTES NO MATERIAL NON-CONFORMANCES, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. A LABELING AND LITERATURE REVIEW WAS COMPLETED. REVIEW OF BIOCOMPATIBILITY OF STAINLESS STEEL FOR USE IN NUVASIVE, INC. MEDICAL INSTRUMENTS FINAL REPORT HAS PROVIDED SUFFICIENT SUPPORTING DOCUMENTATION FOR THE STAINLESS-STEEL TYPE 17-4, STAINLESS STEEL TYPE 455, STAINLESS STEEL TYPE 465, AND STAINLESS-STEEL TYPE 316 USED IN THE NUVASIVE, INC. MEDICAL SURGICAL INSTRUMENTS AT LOCATIONS OF POTENTIAL INSTRUMENT FAILURE TO BE CONSIDERED BIOCOMPATIBLE. THE POTENTIAL LONG-TERM EXPOSURE OF LODGED OR EMBEDDED STAINLESS STEEL MATERIAL IN THE EVENT OF INSTRUMENT FAILURE WAS REVIEWED. THE AFOREMENTIONED MATERIALS WERE DETERMINED TO POSSESS A CHROMIUM OXIDE PASSIVATION LAYER WHICH SERVES TO CREATE A MATERIAL WITH NEGLIGIBLE POTENTIAL FOR LEACHABLE METALLIC ELEMENTS AND VIRTUALLY NO POTENTIAL FOR MATERIAL-INDUCED TOXICITY. THEREFORE, IN SITUATIONS WHERE THE PHYSICIAN HAS DETERMINED THAT REMOVAL OF THE INSTRUMENT FRAGMENT IS NOT POSSIBLE AND THE ONLY SAFE OPTION IS LEAVING IT EMBEDDED IN THE PATIENT, THESE STAINLESS-STEEL MATERIALS CAN BE CONSIDERED TO EXERT VERY LOW TOXICITY POTENTIAL AND TO POSE NEGLIGIBLE RISK TO THE PATIENT. A RISK EVALUATION WAS COMPLETED. REVIEW OF THE COMPLAINT AND ASSOCIATED RISK DOCUMENT 13-005-RM, REV. AR LINES RM-20, RM-40, RM-240, AND U110 FOUND THE EFFECTS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED AND THE SEVERITY OF POSSIBLE EFFECTS DO NOT EXCEED THOSE ESTIMATED IN THE RISK DOCUMENTATION. NO NEW HARM EVENT OR ADVERSE TREND IDENTIFIED WITH THE REPORTED EVENT. ADDITIONALLY, BASED ON THE RISK LEVEL ESTIMATED FOR THIS PRODUCT, THIS COMPLAINT DOES NOT JUSTIFY THE NEED FOR NEW OR ADDITIONAL RISK EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. NO ADVERSE EFFECT TO PATIENT. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039906 RELINE SURGICAL SCREWDRIVER, REUSABLE LXH NUVASIVE, INC. 10000751 NM3960 00887517513724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown